Duloxetine
- Product NDC
- 72789-338
- 11-digit product format
- 727890338
- Labeler code
- 72789
- Product ID
- 72789-338_47a99c63-9a99-5f97-e063-6294a90a3632
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2017-03-16
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Duloxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596934 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-338-90 | Duloxetine | 90 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 90 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-338 | DULOXETINE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 18 | Current NDC, 1 package rows | 20240220_db85a82d-84f1-41c8-964b-ac94ae4d8e7b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-338-90 | 72789033890 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-338-90) | 2023-07-28 | No | No | Historical |